Drugs

CGMP, Other Violations at Indoco Remedies Goa

A 1/17-1/25 FDA inspection at the Indoco Remedies Limited drug manufacturing facility in Goa, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/9 Warning Letter says specific violations were:

failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced;
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failing to ensure that laboratory records included complete data from all tests necessary to ensure compliance with established specifications and standards.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA recommends that Indoco retain a qualified consultant to assist it in data integrity remediation. The company was told to submit (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and (3) a firm management strategy that includes details of its global corrective and preventive action plan.

The letter also says the firm does not have an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.

In addition to recommending a consultant to assist with data integrity remediation, FDA recommends that Indoco retain a consultant to assist it in meeting CGMP requirements.

Indoco was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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